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MYLOTARG™ (gemtuzumab ozogamicin)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
MYLOTARG™ Quick Finder
Highlights
Boxed Warning
WARNING: HEPATOTOXICITY
Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent...
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Indications and Usage
1 INDICATIONS AND USAGE
1.1 Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML)
MYLOTARG is indicated for the treatment of newly-diagnosed CD33-...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Premedication and Special Considerations
- Premedicate adults with acetaminophen 650 mg orally and diphenhydramine 50 mg orally or...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
For injection: 4.5 mg as a white to off-white lyophilized cake or powder in a single-dose vial for reconstitution and further dilution.
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Contraindications
4 CONTRAINDICATIONS
MYLOTARG is contraindicated in patients with a history of hypersensitivity to the active substance in MYLOTARG or any of its components or to any of the excipients. Reactions have included anaphylaxis...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD)
Hepatotoxicity, including life-threatening and sometimes fatal hepatic VOD...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hepatotoxicity, including VOD [see Warnings...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on its mechanism...
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Description
11. DESCRIPTION
Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC). The antibody portion (hP67.6) recognizes...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Formal carcinogenicity studies have not been conducted with gemtuzumab ozogamicin...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Newly-Diagnosed CD33-positive AML
Study ALFA-0701
...
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References
15 REFERENCES
1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
MYLOTARG (gemtuzumab ozogamicin) for injection is a white to off-white lyophilized cake or powder supplied in a carton (NDC 0008-4510-01) containing one 4.5 mg single-dose vial...
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Medication Guide
17. PATIENT COUNSELING INFORMATION
Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD)
Inform patients that liver problems,...
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Resources
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.